This work describes an HPAE-PAD method for monosaccharide composition analysis using manually prepared eluent. Monosaccharide analysis using electrolytically generated eluent has been described before. Here, three commercially available proteins, IgG, fetuin, and alpha-1-acid glycoprotein, were individually subjected to two hydrolysis conditions using 1)HCl, for the amino sugars galactosamine and glucosamine, and 2)TFA, for the neutral sugars mannose, glucose, and galactose. Results for method linearity, robustness, and accuracy are presented here. An ICS-6000 can be used for this application.

The Thermo Scientific Vanquish Flex UHPLC system with UV detection is applied for the charge variants analysis of NISTmAb Humanized IgG1K monoclonal antibody using strong cation exchange-based chromatographic separation on a MAbPac SCX-10 column. The use of Thermo Scientific CX-1 pH gradient buffers enabled high resolution separation of reference material monoclonal antibody charge variants using a 30 minute gradient.

The Thermo Scientific Vanquish UHPLC system with Fluorescence detection is applied for the rapid glyco-profiling of a commercial chimeric IgG1 mAb.The separation is performed on a Thermo Scientific Accucore-150-Amide HILIC column in under 2.5 minutes. The developed methodology offers an excellent analytical platform for ultrafast glycan profile comparison of different batches​ of these mAbs.

The Thermo Scientific Vanquish H system with fluorescence detection is applied for the glycan profile comparison of a biosimilar candidate produced ‘in house’ using Chinese hamster ovary (CHO) cell line using HILIC-based chromatographic separation on Accucore 150-Amide-HILIC column. Developed methodology offers an excellent analytical platform for glycan profile comparison of multiples lots of the biosimilar product.

The Thermo Scientific Vanquish H system with fluorescence detection is applied for the rapid glycoprofiling of a commercial chimeric IgG1 mAb. The separation is performed on a Thermo Scientific Accucore-150-Amide HILIC column in under 2.5 minutes. Developed methodology offers an excellent analytical platform for ultrafast glycan profile comparison of various production batches.